ISO/TR 14969-2004
医疗装置.质量管理系统.ISO 13485-2003应用指南

Medical devices - Quality mangement systems - Guidance on the application of ISO 13485: 2003

标准号

ISO/TR 14969-2004

发布日期

2004年10月

实施日期

废止日期

无

中国标准分类号

C30

国际标准分类号

03.120.10;11.040.01

发布单位

IX-ISO

代替标准

ISO 13485-2016

被代替标准

ISO 14969-1999

适用范围

This Technical Report provides guidance for the application of the requirements for quality management systems contained in ISO 13485. It does not add to, or otherwise change, the requirements of ISO 13485. This Technical Report does not include requirements to be used as the basis of regulatory inspection or certification assessment activities. NOTE The terms “should”, “can” and “might” within this Technical Report are used as follows. “Should” is used to indicate that, amongst several possibilities to meet a requirement in ISO 13485, one is recommended as being particularly suitable, without mentioning or excluding others, or that a certain course of action is preferred but not necessarily required. “Can” and “might” are used to indicate possibilities or options. These terms do not indicate requirements. This guidance can be used to better understand the requirements of ISO 13485 and to illustrate some of the variety of methods and approaches available for meeting the requirements of ISO 13485.

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